The Senior Quality Specialist will be responsible for Corrective and Preventive Action (CAPA) and Non-conformance (NC) processes and related quality activities. The position also supports new quality system/methodologies implementation, training, and problem solving.
This position will also work directly with Site Quality, Global Quality and Site Functions and Departments to provide sustaining quality and compliance leadership in the specific areas related CAPA and Non-conformance, training, and problem solving. In addition, the position is responsible for reporting key quality metrics to drive quality and efficiency.
The position will develop and maintain Nonconformance and CAPA procedures in accordance with applicable requirements.
This position also supports compliance remediation projects.
Other Quality System duties as directed by Quality leadership.
Facilitate implementation of CAPA and NC systems.
Mentor, coach, and guide users of the CAPA and NC systems, including; problem solving tools, root cause investigation, CAPA action determination, CAPA effectiveness.
Monitor quality of CAPA and NC records and work with owners to address issues.
Contribute to the continuous improvement of the CAPA and NC systems based on use patterns and user feedback.
Develop, implement and manage CAPA Review Board.
Develop and report quality metrics on CAPA and NC performance.
Assist functional areas with systematic problem-solving methodologies when resolving issues.
Assure compliance to applicable regulations.
Scope of Position:
The scope of this position is directly related to the Site Quality, Global Quality and Site Functions and Departments.
The position will include routine interaction and communication with internal and external business stakeholders (Quality, Compliance, Supply Chain, R&D, Regulatory, Commercial and External Suppliers).
Bachelor of Science degree in an engineering discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc) is required.
ASQ Certification (such as CQA, CQE, CMQ/QE). Preferred
Lean Six Sigma Certification. Preferred
Demonstrated working experience and expertise in CAPA and non-conformance systems in a regulated industry. Required
Excellent communication skills (verbal and written). Experience in problem solving and root cause analysis. Required
Ability to successfully coordinate and influence other within project teams regarding quality or compliance concerns. Required
Excellent organizational and presentation skills. Required
Minimum 5 years with CAPA and NC in Quality Assurance industry is required, including; root cause analysis and statistical techniques such as Cause and Effect Analysis, 5 Whys, Six Sigma processes. Medical Device or Pharmaceutical is preferred.
Ability to motivate and mentor users to increase proficiency with CAPA and NC management along with problem solving tools. Required.
Expertise in implementing and maintaining quality systems. Required.
Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment. Required.
Familiar with 21 CFR Part 820 and ISO 13485. Preferred.
Experience in electronic quality management systems. Preferred.